Rapidigen
+90 216 346 86 66
  • Testing Just In
    15
    minutes
    for COVID-19
    For the detection of novel coronavirus antigen in human oro-/nasopharyngeal swabs

COVID-19 Ag Test

For the detection of novel corona virus antigen in human oro-/nasopharyngeal swabs

FAST

Gives result only in 15 minutes


ACCURATE

COVID-19 Ag Test detects the antigen of SARS-CoV-2

tripatogen logo

EASY TO USE

Simple to process, esay to interpret.


SENSITIVE

Presence of small amount of viruses are enough to detect

RAPIDIGEN

FAST Test Fast Test

RAPIDIGEN

COVID-19 Ag Test detects the antigen of SARS-CoV-2 (COVID-19) in human oropharyngeal swabs or nasopharyngeal swabs.

COVID-19 Ag Test is a rapid, qualitative, immuno chromatographic assay for the detection of 2019-nCoV antigen in human oropharyngeal swabs or nasopharyngeal swabs.

The test can be performed using human oropharyngeal swabs or nasopharyngeal swabs. The samples should be used as soon as possible after they are collected (with in half an hour).Samples should not be inactivated. Due to the risk of contamination,test should be performed in the appropriate biosafety laboratory protection requirements and with the use of a cabinet. Within the scope of Covid-19 pandemic measures, national guidelines and localregulatory requirements and guidelines on laboratory biosafety should be followed in all circumstances.

Components

  • Test cassettes, sterile swab, sample extraction tube,extraction tube tips, extraction reagent(R), work station and instructions for use.(25-10-5 Tests)
TESTS

TEST
PROCEDURE Test Procedure

The test can be performed using human oropharyngeal swabs or nasopharyngeal swab. The samples should be used as soon as possible after they are collected (with in half an hour). Samples should not be inactivated. Due to the risk of contamination,test should be performed in the appropriate biosafety laboratory protection requirements and with the use of a cabinet. Within the scope of Covid-19 pandemic measures, national guidelines and local regulatory requirements and guidelines on laboratory biosafety should be followed in all circumstances.

SAMPLE COLLECTION AND PREPARATION

For oropharyngeal swab:
Have the patient's head slightly tilted back, mouth open, and "ah" sound, exposing both sides of the pharyngealtonsils.Use a hand swab to gently wipe the pharyngealtonsils on both sides of the patient for at least 3 times, and then wipe them on the posterior pharyngeal wall for at least 3 times.Place the swab specimen into the pre-added extract tube,rotate the swab for about 10 seconds, and press the swab head against the tube wall to release the antigens in the swab.
For nasopharyngeal swab:
Allow the patient's head to relax naturally, and slowly rotate the swab against the nostril wall into the nostril of the patient to the nasal palate, and then slowly rotate it out while wiping. Wipe the other nostril with the same swab,using the same method; place the swab specimen into the pre-added extract tube, rotate the swab for about 10 seconds, and press the swab head against the tube wall to release the antigens in the swab.

The Procedure

  • Bring the tests,reagents and samples to room temperature.
  • Open the pouch and take out the test cassette.
  • Place the test tube to the work station. The extraction reagent(R) is pressed vertically downward to allow the solution to drip freely into the extraction tube without touching the edge of the tube.Add 6 drops of extraction reagent to the extraction tube (Figure 1).
  • Put the swab specimen into the extraction tube (Figure 2).
  • Rotate the swab for more than 5 times (about 10 seconds), and press the swab head against the tube wall to release the antigen in the swab. Squeeze the swab over the head to remove the swab so as to remove as much liquid as possible from the swab .
  • Place the extraction tube tip tightly on top of the test tube (Figure 3).
  • Put two drops into the sample well of the test cassette, and start the timer(Figure 4).
  • Results should be read in 20 minutes as shown below. Results forming after 30 minutes should be regarded as invalid.

INTERPRETATION OF RESULTS



Negative : Only one colored line is visible in “C” area.
Positive:One colored line should be in ”C“ area and a colored line appears in “T” area.
NOTE:Low concentration of the virus antigens in the sample may cause a faint line in “T” area. Even such a faintline in “T” area should be regarded as “positive”.
Invalid:Nocolored line is visible or only one colored line is visible in “T” area; test should be repeated using a new test device.

QUALITY CONTROL QUALITY

Tests have built in procedural quality control features. When the test is complete, the user will see a colored line in the “C” area of the test on negative samples and a colored line in the “T” and “C” area on positive samples. The appearance of the control “C” line is considered as an internal procedural control. This line indicates that sufficient volume of sample was added as well as valid test result. It is recommended that a negative control and a positive control be used to verify proper test performance as an external control. Users should follow appropriate federal, state and local guidelines concerning the external quality controls.

PERFORMANCE EVALUATION

COVID-19 Ag Test has been evaluated using clinical samples.PCR methods are used to compare COVID-19 Ag Test and following results are obtained.

COVID-19 Ag Test PCR Test TOTAL
POSITIVE NEGATIVE
POSITIVE74276
NEGATIVE6238244
TOTAL80240320

Analysis of coincidence rate of COVID-19 Ag Test and PCR Test in nasopharyngeal samples:

Sensitivity:
74/ (74+6) × 100% = 92.5%

Specificity:
238 / (2+238) × 100% = 99.16%

Accuracy:
(74+238) / (74+6+2+238) × 100% = 97.7%

PRECAUTIONS AND LIMITATIONS

  • 1. For professional and in vitro diagnostic use only.
  • 2. Read this insert completely and carefully priorto use of the test. Test must be performed in strict accordance with these instructions to obtain accurate results.
  • 3. Do not use test kit beyond expiry date. The test device is single use. Do not reuse.
  • 4. The test device should remain in its original sealed pouch until usage. Do not use the test if the seal is broken or the pouch is damaged.
  • 5. Wear disposable gloves while performing the test.
  • 6. The test device and swabs should be discarded in a proper biohazard container after testing.
  • 7. This test kit should be handled only by a dequately qualified personnel trained in laboratory procedures and familiar with the irpotential hazards. We arappropriate protective clothing, gloves and eye/face protection and handle appropriately with the requisite Good Laboratory Practices.
  • 8. The accuracy of the test depends on the sample collection process.Improper sample collection,improper sample transportation and storage or freezing and thawing of the sample will affect the test results.
  • 9. All patient samples should be handled as taking capable of transmitting disease into consideration.Observe established precautions against microbiological hazards through
  • out all procedures and follow the standard procedures for proper disposal of samples.
  • 10. This reagent can only qualitatively detect 2019-nCoV antigens in human nasopharyngeal swab, oropharyngeal swab. It cannot determine the certain amount of antigen content in the samples. As with all diagnostic tests,it should be kept in mind that an identification diagnosis can't be based on a single testresult. Diagnosis can only be reached by an expert after the evaluation of all clinical and laboratory findings. Judgement should be made along with RT-PCR results, clinical symptoms, epidemic condition and further clinical data.
  • 11. It is optimum when eluting swabs with the extraction reagent in the test kits. Using other reagent may result in wrong results.
  • 12. In the early stage of infection,the test result may be negative because the low 2019- nCoV antigen level or antigen has not yet appeared in the sample.
  • 13. A negative result does not exclude the possibility of SARS-CoV-2(COVID-19)infection. The positive result should not be taken as a confirmed diagnosis. Judgement should be made along with clinical symptoms and further diagnosis methods.
  • 14. Sensitivity may decrease if the sample did not tested after directly collected. Please test the sample as soon as possible.
  • 15. Cross reactions maybe exist due to the N protein in SARS has a high homology with the SARS-CoV-2.
  • 16. Analysis the possibility of false negative results:
    a) In appropriate sample collection, using other non-matching reagent with the test kits,the time between sample transfer and test is too long(more than half an hour),the volume of reagent added when eluted the swabs are too much,wrong application of test protocols for elution operation,low virus titer in the sample,these may all lead to false negative results.
    b) Mutations in viral genes may lead to changes in antigen epitope, leading to false negative results.
  • 17. Analysis the possibility of false positive results:
    a) In appropriate sample collection, using other non-matching reagent with the test kits, wrong application of test protocols for elution operation,these may all lead to false positive results.
    b) Cross-contamination of samples may lead to false positive results.
  • 18.If the test result is negative and clinical symptoms persist, additional testing using other clinical methods is recommended. A negative result does not at anytime preclude the possibility of coronavirus.